USA - Quality Assurance Engineer III - CTQ
 Equiliem | |
 United States, South Carolina, Ladson | |
 Feb 19, 2025 | |
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Job Title Eng, Qua, Assurance - CtQ
Summary In this contract role, is under our Commitment to Quality Program. The Quality Engineer- CtQ role is responsible for the implementation of materials master, receiving inspection plans and regulatory compliance to ensure our products meet the highest standards of quality and safety. This role works closely with cross-functional teams to create, maintain and improve our quality management systems, ensuring compliance with ISO 13485, and other regulatory requirements. Key Responsibilities Commitment to Quality * Develop, implement, and maintain robust quality systems and procedures in line with ISO 13485, MDSAP Certifications and other industry standards. * Perform assessments to ensure adherence and commitment to quality specifications and regulatory requirements. SAP Quality Management (QM) Integration * Create inspection plans in SAP * Use the SAP QM module to manage inspections plans, record quality data, and document quality notifications. * Ensure accurate data capture and traceability of quality-related information throughout the product lifecycle. * Set up materials-master maintenance and complete system data correction in SAP fields and inventory locations to ensure data accuracy and warehouse optimization. * Collaborate with IT, Planning, Supply Chain and production teams to optimize SAP processes for quality management. Inspection and Testing * Provide oversight for inspections and tests of raw material, components, and assist with finished product inspections using industry standard techniques. * Review and interpret technical documents, including design specifications, engineering drawings, and regulatory standards Risk Management & Continuous Improvement * Assist with product quality investigations, root cause analysis and CAPA facilitation to address quality issues. * Supports risk management activities, including risk assessments and mitigation plans in compliance with design controls. * Supports process improvements and facilitates PDCA process for production * Assists with Non-Conforming Material process. Qualifications & Skills * Demonstrates high level analytical skills to identify improvement opportunities and develop workable solutions to resolve complex problems * Strong attention to detail and the ability to work collaboratively in a cross-functional team. * Proactive mindset with a commitment to continuous improvement. Education & Experience Education: - Bachelor's degree in engineering, Quality Management or another related technical field. Experience: - 3+ years of experience in a quality engineering role or an equivalent level of knowledge in medical devices. - Proven hands-on experience with SAP, particularly the quality management module. Hours: Monday to Friday 8:00AM to 5:00PM Onsite | |